What is Infanrix Hexa?
Infanrix Hexa is a vaccine that comes in the form of a powder and solvent, to be mixed to obtain a solution for injection. The medicine contains the following active ingredients: toxoids (chemically weakened toxins) of diphtheria and tetanus, parts of Bordetella pertussis (the bacterium that causes pertussis), parts of the hepatitis B virus, inactivated polioviruses and polysaccharides sugars from the bacterium Haemophilus type b influenzae ( Hib, a bacterium that causes meningitis).
What is Infanrix Hexa used for?
Infanrix Hexa is used to vaccinate children under the age of three against diphtheria, pertussis, hepatitis B, poliomyelitis and diseases caused by the bacterium Hib (such as bacterial meningitis). The medicine is also used for booster vaccinations.
The medicine can only be obtained with a prescription.
How is Infanrix Hexa used?
The recommended vaccination schedule for Infanrix Hexa is two or three doses, given at least one month apart, usually within the first six months of life.
Infanrix Hexa is given as a deep intramuscular injection. The injection site should be alternated for subsequent administrations. A booster dose of Infanrix Hexa or a similar vaccine should be given at least six months after the last dose of the initial series. The choice of vaccine to use depends on official recommendations. Infanrix Hexa can be given to children vaccinated against hepatitis B at birth.
How does Infanrix Hexa work?
Infanrix Hexa is a vaccine. Vaccines act by "teaching" the immune system (the body's natural defense system) to defend itself against a disease. Infanrix Hexa contains small amounts of:
- toxoids from the bacteria that cause diphtheria and tetanus;
- toxoids and other purified proteins from the bacterium B. pertussis ;
- surface antigen (proteins from the outer membrane) of the hepatitis B virus;
- inactivated polioviruses (type 1, 2 and 3);
- polysaccharides extracted from the membrane surrounding the bacterium Hib . Polysaccharides are chemically bonded to tetanus toxoid as a vehicle protein as this improves the response to the vaccine.
When a person is vaccinated, the immune system recognizes the fragments of the virus as "foreign" and produces antibodies against that virus. In case of exposure to viruses or bacteria after vaccination, the immune system will be able to produce antibodies more quickly. thus protecting against diseases caused by these microorganisms.
The vaccine is "adsorbed", ie the active ingredient is fixed on aluminum compounds to stimulate a better response.
The surface antigens of the hepatitis B virus produced with a method known as "recombinant DNA technology": that is, they are produced by a yeast into which a gene (DNA) has been introduced that makes it capable of producing the substance.
Infanrix Hexa is a combination of components already available in the European Union (EU) in other vaccines: elements of diphtheria, tetanus, pertussis and hepatitis B bacteria have been available in Infanrix HepB from 1997 to 2005, elements of bacteria of diphtheria, tetanus, pertussis, polioviruses and the Hib bacterium are available in other vaccines
What studies have been carried out on Infanrix Hexa?
Infanrix Hexa has been studied in nine studies, out of a total of almost 5, 000 children at least six weeks old. Over 3, 000 children received the initial vaccination series with Infanrix Hexa. The effects of Infanrix Hexa have been compared to those of other separate vaccines containing the same active ingredients. The main measure of effectiveness in this study was the production of antibodies in children.
Another five studies looked at the effects of a booster vaccination with Infanrix Hexa.
What benefit has Infanrix Hexa shown during the studies?
The nine studies showed that the initial series of vaccination with Infanrix Hexa is equally effective in producing protective levels of antibodies from separate vaccines containing the same active ingredients. Overall, between 95 and 100% of infants developed antibodies against diphtheria, tetanus, pertussis, poliovirus and the Hib bacterium one month after initial vaccination. Other studies have shown that booster vaccinations with Infanrix Hexa were as effective as separate vaccines containing the same active ingredients one month after vaccine administration.
What is the risk associated with Infanrix Hexa?
The most common side effects found with Infanrix Hexa (seen in more than one dose in 10 of the vaccine) are: loss of appetite, fever at 38 degrees Celsius and beyond, swelling, pain and roasting at the injection site, fatigue, abnormal crying, irritability and and restlessness. For the full list of all side effects reported with Infanrix Hexa, see the Package Leaflet.
Infanrix Hexa should not be used in children who may be hypersensitive (allergic) to the active substances or to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics) or if children have had an allergic reaction after a vaccination containing elements from diphtheria, tetanus, pertussis bacteria, hepatitis B virus, poliomyelitis or the bacterium Hib . Infanrix Hexa should not be given to children with encephalopathies (a brain disease) of unknown causes in the seven days following a vaccination containing components of the pertussis bacterium. Infanrix Hexa vaccination should be postponed in children with a sudden high fever.
As with all vaccines, if Infanrix Hexa is given to very premature infants there is a risk that it causes an apnea (short pause in breathing). Breathing of infants must therefore be checked up to three days after vaccination.
Why has Infanrix Hexa been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Infanrix Hexa outweigh the risks for the initial and booster vaccination of children against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and pathologies caused by Hib . The committee recommended the granting of the marketing authorization for Infanrix Hexa.
More information on Infanrix Hexa
On 23 October 2000, the European Commission granted GlaxoSmithKline Biologicals sa a marketing authorization for Infanrix Hexa, valid throughout the European Union. The marketing authorization was renewed on 23 October 2005.
The full EPAR for Infanrix Hexa can be found here.
Last update of this summary: 11-2008.
